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Effects of Deployment Exposures on Cardiopulmonary and Autonomic Function (AirHzds)

This study has been completed.
Information provided by (Responsible Party):
VA Office of Research and Development Identifier:
First received: December 18, 2012
Last updated: January 10, 2017
Last verified: January 2017
Following deployment to Operations Enduring and Iraqi Freedom and Operation New Dawn (OEF/OIF/OND), Veterans report breathing problems, difficulty exercising and other symptoms. These symptoms may be related to deployment exposures, such as regional dust and sand, smoke from burning trash, and local industry. Studies have reported poor air quality, but very little is known about the effect that exposure to this polluted air may have on Veterans' short- and long-term health. Investigators will determine whether deployment-related exposures have affected respiratory and nervous system function in these Veterans - data that may then be used to guide rehabilitation. Ultimately, the investigators' long-term goal is to prevent the development of chronic respiratory conditions in this group of OEF/OIF/OND Veterans.

Abnormality, Respiratory System
Autonomic Nervous System

Study Type: Observational
Study Design: Time Perspective: Cross-Sectional
Official Title: Effects of Deployment Exposures on Cardiopulmonary and Autonomic Function

Further study details as provided by VA Office of Research and Development:

Primary Outcome Measures:
  • FEV1 [ Time Frame: Pre/post exercise; cross-sectional ]
    Forced expiratory volume in 1 second (FEV1) measured before and after an exercise challenge

  • VO2 Peak [ Time Frame: At peak exercise; cross-sectional ]
    Maximal oxygen consumption measured during exercise

  • Heart Rate Variability [ Time Frame: Resting baseline; cross-sectional ]
    Ratio of low-frequency to high-frequency power for heart rate variability

Biospecimen Retention:   None Retained
No biospecimens will be collected

Enrollment: 50
Study Start Date: November 2013
Study Completion Date: December 2015
Primary Completion Date: August 2015 (Final data collection date for primary outcome measure)
Veterans deployed to OEF/OIF/OND and environmentally exposed to high levels of particulate matter
OEF/OIF/OND Veterans deployed to regions other than Southwest Asia

Detailed Description:

Evidence is clear that Veterans deployed to Operations Enduring and Iraqi Freedom and Operation New Dawn (OEF/OIF/OND) have been exposed to high levels of particulate matter (PM) that exceeded environmental, occupational and military exposure guidelines. PM exposure is acknowledged as a risk factor for cardiovascular morbidity and mortality, and can increase the risk of and exacerbate airway disease. The reviewed epidemiology indicates a high prevalence of newly reported respiratory symptoms in OEF/OIF/OND Veterans that has significantly affected their deployment duties, including their physical exertion capability. Despite these retrospective data and limited air sampling reports, prospective studies are lacking. This pilot study will evaluate cardiorespiratory and autonomic function in OEF/OIF/OND Veterans as compared to Veterans never deployed to the region.

To evaluate cardiopulmonary function, each Veteran will undergo a standardized exercise challenge and bronchodilator spirometry. To evaluate autonomic nervous system function, investigators will examine indices of heart rate variability and cardiovascular reflex regulation (e.g. baroreflex sensitivity and cerebral autoregulation) during a variety of tasks.

Data derived from this pilot project will yield important insight on the extent and severity of cardiorespiratory and/or autonomic impairments - data that may provide intervention points for attenuating long-term adverse outcomes such as pulmonary and cardiovascular disease. Through early identification, treatment options (e.g. exercise therapy, pharmaceutical) may be implemented to enhance physiological function, with the goal of helping to alleviate symptoms and reduce chronic disease risk.


Ages Eligible for Study:   18 Years to 55 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Community sample, outpatient clinic

Inclusion Criteria:

  • Male and female Veterans between 18 - 55 years of age will be identified and screened for this study.
  • Two study cohorts will be recruited and attempts will be made to match group composition on age, body mass index and smoking history.
  • Veterans assigned to the Exposed group must have been deployed to OEF/OIF for a minimum of 90 consecutive days.
  • The Control group will consist of Veterans never deployed to Southwest Asia (i.e. OEF/OIF, Persian Gulf War) but were deployed during the same time period.
  • Each Veteran will complete a detailed exposure history questionnaire to confirm and support their group assignment.

Exclusion Criteria:

Participants must not meet any of the contraindications to exercise testing as described in the joint statement from the American College of Cardiology and American Heart Association. Also, individuals with history of any of the following will also be excluded:

  • asthma (pre-military)
  • cardiovascular disease
  • neurological impairment/disorder
  • pregnant
  • uncontrollable hypertension (SBP > 160; DBP > 100)
  • or have suffered severe/moderate traumatic brain injury within the last three years
  • eye/chest/abdominal surgery in last 3 months
  • tuberculosis exposure to self or household member
  • history of aneurysm or collapsed lung
  • history of detached retina
  • stroke or heart attack in the last 3 months
  • and history of coughing up blood in last three months

(With the exception of hypertension and pregnancy (urine test), all exclusion criteria will be determined via self-report)

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Please refer to this study by its identifier: NCT01754922

United States, New Jersey
East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
East Orange, New Jersey, United States, 07018
Sponsors and Collaborators
VA Office of Research and Development
Principal Investigator: Michael Joseph Falvo, PhD East Orange Campus of the VA New Jersey Health Care System, East Orange, NJ
  More Information

Additional Information:
Responsible Party: VA Office of Research and Development Identifier: NCT01754922     History of Changes
Other Study ID Numbers: F1079-P
1I21RX001079-01A ( Other Grant/Funding Number: VA ORD RR&D )
1I21RX001079-01 ( US NIH Grant/Contract Award Number )
Study First Received: December 18, 2012
Results First Received: July 18, 2016
Last Updated: January 10, 2017

Keywords provided by VA Office of Research and Development:
exercise tolerance
operation enduring freedom
operation Iraqi freedom

Additional relevant MeSH terms:
Respiratory System Abnormalities
Respiratory Tract Diseases
Congenital Abnormalities processed this record on April 28, 2017